Weighted Specula-Steiner, Henrotin, Berland, Garrigue

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K891037 ↗

FDA Product Code

HFD

Device Class

Class II

Regulation

21 CFR Part 884.1185

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Scissors: Thorek, Jorgensen, Finochietto

  Class I

  FDA 510(k) K891203 Active Cleared 6 Apr 1989

• Zeppelin Scissors

  Class I

  FDA 510(k) K891049 Active Cleared 17 Mar 1989

• Rectal Specula - Chelsea-Eaton, Kelly, Mathieu

  Class I

  FDA 510(k) K892542 Active Cleared 9 May 1989

• Zsi Biopsy Forceps

  Class I

  FDA 510(k) K891027 Active Cleared 17 Mar 1989

• Dental Root Elevator

  Class II

  FDA 510(k) K892255 Active Cleared 1 May 1989

• Vaginal Retractors - Kristeller, Delee, Breisky

  Class I

  FDA 510(k) K891038 Active Cleared 17 Mar 1989

See all devices from Zinnanti Surgical Instruments, Inc. →

• What is the primary clinical use of the Weighted Specula-Steiner, Henrotin, Berland, Garrigue?

  This device is specifically designed as an endometrial washer for use in obstetrics and gynecology procedures. Its primary function is to facilitate visualization and access during clinical examinations.

• What is the regulatory classification of this device?

  The device is classified as a class 2 medical device under regulation number 884.1185. It has received FDA 510(k) clearance under K891037, confirming it is substantially equivalent to predicate devices.

• Who is the manufacturer of these specula models?

  These instruments are manufactured by Zinnanti Surgical Instruments, Inc., located in Chatsworth, California.